Q-PRAVASTATIN TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
31-05-2013
この製品の一部のドキュメントは現在利用できません。カスタマーサービスにリクエストを送信できます。入手可能になり次第、お知らせします。
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有効成分:
PRAVASTATIN SODIUM
から入手可能:
QD PHARMACEUTICALS ULC
ATCコード:
C10AA03
INN（国際名）:
PRAVASTATIN
投薬量:
40MG
医薬品形態:
TABLET
構図:
PRAVASTATIN SODIUM 40MG
投与経路:
ORAL
パッケージ内のユニット:
30/100
処方タイプ:
Prescription
治療領域:
HMG-COA REDUCTASE INHIBITORS
製品概要:
Active ingredient group (AIG) number: 0122563003; AHFS:
認証ステータス:
CANCELLED PRE MARKET
承認日:
2015-08-21
製品の特徴
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PRODUCT MONOGRAPH
PR
Q-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 164225
Date of Revision: May 31, 2013
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION ............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
32
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